The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Mini Plating System.
| Device ID | K043142 |
| 510k Number | K043142 |
| Device Name: | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408006111 | K043142 | 000 |
| 06438408006395 | K043142 | 000 |
| 06438408006401 | K043142 | 000 |
| 06438408006418 | K043142 | 000 |
| 06438408006425 | K043142 | 000 |
| 06438408006432 | K043142 | 000 |
| 06438408006449 | K043142 | 000 |
| 06438408006579 | K043142 | 000 |
| 06438408006586 | K043142 | 000 |
| 06438408010613 | K043142 | 000 |
| 06438408010637 | K043142 | 000 |
| 06438408010644 | K043142 | 000 |
| M224FRF12069 | K043142 | 000 |
| M224FRF12079 | K043142 | 000 |
| M224FRF12179 | K043142 | 000 |
| 06438408006388 | K043142 | 000 |
| 06438408006371 | K043142 | 000 |
| 06438408006128 | K043142 | 000 |
| 06438408006135 | K043142 | 000 |
| 06438408006197 | K043142 | 000 |
| 06438408006265 | K043142 | 000 |
| 06438408006272 | K043142 | 000 |
| 06438408006289 | K043142 | 000 |
| 06438408006296 | K043142 | 000 |
| 06438408006302 | K043142 | 000 |
| 06438408006319 | K043142 | 000 |
| 06438408006326 | K043142 | 000 |
| 06438408006333 | K043142 | 000 |
| 06438408006340 | K043142 | 000 |
| 06438408006357 | K043142 | 000 |
| 06438408006364 | K043142 | 000 |
| M224FRF12349 | K043142 | 000 |
| M224FRF12489 | K043142 | 000 |
| M224FRF12679 | K043142 | 000 |
| M224FRF12689 | K043142 | 000 |
| M224FRF12699 | K043142 | 000 |
| M224FRF12709 | K043142 | 000 |
| M224FRF12719 | K043142 | 000 |
| M224FRF13049 | K043142 | 000 |
| M224FRF13059 | K043142 | 000 |
| M224INS908010 | K043142 | 000 |
| M224INS90809 | K043142 | 000 |
| M224INS908110 | K043142 | 000 |
| M224INS90819 | K043142 | 000 |
| M224INS908210 | K043142 | 000 |
| M224INS90829 | K043142 | 000 |
| M224INS911410 | K043142 | 000 |
| M224FRF12669 | K043142 | 000 |
| M224FRF12659 | K043142 | 000 |
| M224FRF12499 | K043142 | 000 |
| M224FRF12509 | K043142 | 000 |
| M224FRF12519 | K043142 | 000 |
| M224FRF12529 | K043142 | 000 |
| M224FRF12539 | K043142 | 000 |
| M224FRF12559 | K043142 | 000 |
| M224FRF12569 | K043142 | 000 |
| M224FRF12579 | K043142 | 000 |
| M224FRF12589 | K043142 | 000 |
| M224FRF12599 | K043142 | 000 |
| M224FRF12609 | K043142 | 000 |
| M224FRF12619 | K043142 | 000 |
| M224FRF12629 | K043142 | 000 |
| M224FRF12649 | K043142 | 000 |
| M224INS91149 | K043142 | 000 |